Animex
by Uro Technology Sdn. Bhd. Malaysia EUDAMED
Ref 10286, 10284, 10291, 10289, 10309, 10288, 10307 EMDN U010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-09555942811005 | Date18 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Sterile Urethral Latex Foley Balloon Catheters
- Model / Reference
- 10286, 10284, 10291, 10289, 10309, 10288, 10307
- Primary DI / UDI-DI
- 09555942811005, 09555942810985, 09555942811050, 09555942811036, 09555942811104, 09555942811029, 09555942811081
- Basic UDI-DI
- B-09555942811005, B-09555942810985, B-09555942811050, B-09555942811036, B-09555942811104, B-09555942811029, B-09555942811081
- EMDN Code
- U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
- Device Class
- Class IIb
- Market of Registration
- Greece
Manufacturer details
- EUDAMED SRN
- MY-MF-000001248
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Uro Technology Sdn. Bhd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Reusable: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (7)
- EUDAMED 64be58e0-8efa-43eb-b008-47f3a0eabb5f
- EUDAMED 09555942810985|B-09555942810985
- EUDAMED 09555942811050|B-09555942811050
- EUDAMED 09555942811036|B-09555942811036
- EUDAMED 09555942811104|B-09555942811104
- EUDAMED 09555942811029|B-09555942811029
- EUDAMED 09555942811081|B-09555942811081